← Back to Search

Chemotherapy

Chemo/Immunotherapy Combo for Head and Neck Cancer

Phase 2

Recruiting

Led By Thomas Lycan, DO

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not a candidate for infusional 5FU (mucositis, 5-day infusional pump not feasible, patient refusal, other).

Patients must have normal organ and marrow function as defined: Absolute neutrophil count greater than or equal to 1,000/mcL, platelets greater than or equal to 75,000/mcL, total bilirubin less than or equal to 2 mg/dL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing a new chemo/immunotherapy combo to treat head/neck squamous cell carcinoma for patients unable to take 5-fluorouracil.

Who is the study for?

This trial is for adults with advanced head/neck squamous cell carcinoma that can't be cured by surgery or radiation, and who cannot take the drug 5-fluorouracil. Participants need to have a certain level of physical fitness (ECOG 0-2) and adequate organ function. Pregnant women, individuals with untreated brain metastases, severe allergies to chemo drugs used in this study, active autoimmune diseases requiring steroids, or any serious health issues that could interfere with the trial are excluded.Check my eligibility

What is being tested?

The study tests weekly chemotherapy (carboplatin and paclitaxel) combined with immunotherapy (pembrolizumab) on patients with metastatic head/neck cancer who can't receive standard treatment. The goal is to evaluate the effectiveness and safety of this regimen in controlling cancer progression.See study design

What are the potential side effects?

Possible side effects include allergic reactions to chemo drugs, immune-related problems like inflammation of organs due to pembrolizumab, blood cell count changes leading to increased infection risk or bleeding problems, fatigue from treatment burden, and potential harm to an unborn child.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I cannot receive 5FU treatment due to side effects, practical issues, or personal choice.

Select...

My blood tests show normal organ function and healthy blood cell counts.

Select...

I can take care of myself and perform daily activities.

Select...

My cancer has returned or spread and cannot be cured with surgery or radiation.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response Rate

Secondary outcome measures

Number of Participants with Discontinuation of Study Drug due to Adverse Effects of Any Cause

Overall Survival

Progression-Free Survival

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Combination of Chemotherapy and ImmunotherapyExperimental Treatment3 Interventions

The intervention will be administered on an outpatient basis. The treatment regimen will consist of combination chemotherapy and immunotherapy administered as: Pembrolizumab PLUS Carboplatin PLUS Paclitaxel.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5380

Carboplatin

2014

Completed Phase 3

~6670

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,242 Previous Clinical Trials

1,004,232 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,925,971 Total Patients Enrolled

Thomas Lycan, DOPrincipal InvestigatorWake Forest Baptist Health Sciences

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04858269 — Phase 2

Head and Neck Cancers Research Study Groups: Combination of Chemotherapy and Immunotherapy

Head and Neck Cancers Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04858269 — Phase 2

Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04858269 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there prior evidence to suggest the efficacy of Pembrolizumab?

"Currently, 1988 studies are underway examining the efficacy of Pembrozilumab. Of those clinical trials in operation, 413 have moved onto Phase 3 testing. Most of these research centres are located in Shanghai; however 91405 other locations across the world also contain active tests for this medication."

Answered by AI

Could you tell me the size of this clinical trial participant cohort?

"Affirmative. According to clinicaltrials.gov, this medical trial is currently recruitment eligible individuals and has been since its May 27th 2021 listing. The most recent update was made on August 8th 2022, with the goal of enlisting 35 patients at a single facility."

Answered by AI

What conditions is Pembrolizumab widely employed to treat?

"Pembrolizumab is a therapeutic agent used to treat malignant neoplasms and conditions such as inoperable melanoma, microsatellite instability high, and severe risk of recurrence."

Answered by AI

Are enrollment opportunities currently available for this research endeavor?

"According to the data available on clinicaltrials.gov, this medical investigation is still actively recruiting participants. It was initially posted on May 27th 2021 and most recently updated on August 8th 2022."

Answered by AI